YY 0784-2010: Medical electrical equipment. Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use

Delivery: 9 seconds. Download (and Email) true-PDF + Invoice.
Get Quotation: Click YY 0784-2010 (Self-service in 1-minute)
Newer / historical versions: YY 0784-2010

Preview True-PDF

Scope

Reference to Chapter 1 of GB 9706.1-2007 does not include the following.
Modify (at the end of 1.1)
This standard describes in detail the specific safety and essential performance requirements for pulse oximetry equipment suitable for use in humans.
Including any necessary components in normal use, such as pulse oximetry, pulse oximetry, probe cable extension cord, and so on.
These requirements also apply to reprocessed pulse oximetry equipment, including pulse oximetry, oximetry and probe cable extension
Line and so on.
The range of application of the pulse oximeter device includes, but is not limited to, estimating arterial oxygen saturation in a patient in a health care facility and in a home
Degree and pulse rate.
This standard does not apply to pulse oximetry equipment used in laboratory studies and is not applicable to blood oxygen meters where blood samples are to be collected.
This standard does not apply to fetal pulse oximeter equipment.
This standard does not apply to telemetry or master (slave) devices that display SpO2 values outside the patient's environment.
The requirements of this standard replace or modify GB 9706.1-2007 and are expected to take precedence over the corresponding general requirements.

Basic Data

Standard ID	YY 0784-2010 (YY0784-2010)
Description (Translated English)	Medical electrical equipment. Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C39
Classification of International Standard	11.040.55
Word Count Estimation	78,739
Date of Issue	2010-12-27
Date of Implementation	2012-06-01
Quoted Standard	GB/T 2423.5-1995; GB/T 2423.8-1995; GB/T 2423.10-2008; GB/T 2423.56-2006; GB 4208-2008; GB/T 5332-2007; GB/T 5465.2-2008; GB 7247.1-2001; GB 9706.1-2007; GB 9706.15-2008; GB/T 19974-2005; YY 0466-2003; YY 0505-2005; YY/T 0708-2009; YY 0709-2009; IEC 60601-1-6-2004; IEC 60825-2-2000; ISO 14155-1-2003; ISO 14155-2-2003
Adopted Standard	ISO 9919-2005, IDT
Regulation (derived from)	State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the use of human pulse oximeter equipment, basic safety and essential performance requirements for the device is included in the normal use of any necessary parts, such as pulse oximeter monitor, pulse oximeter probe, extension cable lines. These requirements also apply after reprocessing pulse oximeter equipment, including pulse oximeter monitors, oxygen probe and the probe cable lengths. Pulse oximeter equipment range of applications including, but not limited to, health care institutions and households in the estimated patient's arterial oxygen saturation and pulse rate. This standard does not apply to laboratory studies using pulse oximetry equipment, nor to be applied to the patient's blood samples collected oximeter. This standard does not apply to the fetus dedicated pulse oximeter devices. This standard does not apply to be placed on the outside of the patient environment display SpO2: numerical telemetry or master (from) device.